Systems and methods for personalized oral irrigation

ABSTRACT

Described herein are systems and methods for providing personalized oral irrigation. One variation of a system for personalized oral irrigation comprises a fluid reservoir and a customized oral insert in fluid communication with the fluid reservoir. The oral insert comprises an arrangement of fluid openings positioned based on the individual oral or dental structures of a user&#39;s teeth to provide a customized fluid flow over the user&#39;s teeth. Also described herein are methods for generating an arrangement of fluid openings in a customized oral insert.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/024,373, filed on Jun. 29, 2018, which claims priority to U.S.Provisional Patent Application No. 62/527,955, filed Jun. 30, 2017, thedisclosure of each of which is hereby incorporated by reference in itsentirety.

TECHNICAL FIELD

The disclosure provided herein relates to systems and methods for oralcare.

BACKGROUND

Gum disease is a widespread condition that affects public health andquality of life. The tools we use to take care of our teeth areoutdated. Toothbrushes have existed since 619 AD and floss has existedsince 1819 AD. Brushing and flossing are woefully inadequate forcomprehensive oral and dental care. Furthermore, few adults includeflossing as part of their regular dental hygiene, which may contributeto high rates of periodontal disease and tooth loss. Poor dental andoral health may contribute to a shortened life span and other ailments.

Clinical studies indicate that water flossers (such as WATERPIK®) may beeffective at cleaning in between the teeth and around the gums. However,water flossing can be too messy for some, and it can be time-consumingand challenging to position a water flosser at an optimized cleaninglocation for each tooth. Given the myriad oral geometries that blossomfrom the diverse nature of human physiology, achieving sufficientcleaning efficacy with a water flosser may also be difficult.

SUMMARY

Described herein are systems and methods for providing personalized oralirrigation. A system for personalized oral irrigation may comprise afluid reservoir and a customized oral insert in fluid communication withthe fluid reservoir. The oral insert may comprise an arrangement offluid openings positioned to provide a customized fluid flow over auser's teeth. In some variations, the oral insert may be customized toaccommodate a user's oral geometry. Fluid egress from the plurality offluid openings may clean multiple teeth simultaneously and the locationand geometry of the fluid openings with respect to specific and uniquestructures of the user's mouth may help facilitate expeditious and/oreffective cleaning of teeth surfaces. In some variations, the oralinsert may comprise a custom arrangement of a plurality of fluidopenings or nozzles where each of the nozzles is positioned to target aspecific dental feature or structure.

One variation of a customized system for oral irrigation may comprise afluid reservoir and a customized oral insert in fluid communication withthe fluid reservoir. The customized oral insert may comprise one or moreoral alignment structures and an arrangement of fluid openingspositioned to provide a customized fluid flow path across or in betweenone or more teeth of a user. The arrangement of fluid openings may bedetermined based on at least one characteristic of one or more teeth.The one or more oral alignment structures may comprise a plurality ofcontours that correspond to the one or more teeth. The at least onecharacteristic may comprise the geometry of at least one tooth. The atleast one characteristic may, alternatively or additionally, comprisethe size and shape of one or more interproximal regions that may belocated between the teeth, and the arrangement of fluid openings maycomprise a plurality of openings oriented parallel to correspondinginterproximal regions and located within about 0 mm to about 10 mm fromthe corresponding interproximal region. The at least one characteristicmay alternatively or additionally comprise the contours of the planarsurfaces of the teeth, and the arrangement of fluid openings maycomprise a plurality of openings oriented perpendicular to correspondingplanar surfaces and located within about 0 mm to about 10 mm from thecorresponding planar surface. The at least one characteristic mayalternatively or additionally comprise the size and shape of teethgingival margins. The arrangement of fluid openings may comprise aplurality of openings oriented at an angle from about 0° to about 90°relative to the tooth's surface at the gingival margin, for example,from about 45° to about 135°, from about 0° to about 45°, from about 35°to about 55°, about 45°, etc. The fluid openings may be located withinabout 0 mm to about 10 mm from the corresponding gingival margin.Alternatively or additionally, the at least one characteristic maycomprise the geometry of other oral and/or dental devices, for example,permanent and removable dental restorations/prosthetics, orthodonticappliances, and the like (e.g., crowns, bridges, implants, braces,retainers, dentures, and the like). One variation of a system maycomprise a handle and the oral insert may be coupled to the handle. Thehandle may comprise a fluid flow management module that regulates fluidingress to the oral insert. The oral insert may comprise one or moremanifolds in fluid communication with the fluid flow management module.The number and geometry of the one or more manifolds may be determinedin part based on the arrangement of fluid openings and at least onecharacteristic of the one or more teeth.

Also disclosed herein are methods of generating an arrangement of fluidopenings in an oral insert. One variation of a method may compriseobtaining oral structure data comprising the size, shape, and locationof a user's teeth and gums, calculating an oral surface map thatidentifies locations of gingival margins, interproximal regions, incisaledges, and contours of the occlusal, facial, lingual, mesial and distalsurfaces of the teeth, and generating an arrangement of fluid openingsin an oral insert, where the arrangement of fluid openings correspondsto the location of the gingival margins, interproximal regions, incisaledges, and contours of the occlusal, facial, lingual, mesial and distalsurfaces of the teeth. Obtaining oral structure data may compriseacquiring a 3-D dental scan and/or acquiring X-ray dental image(s),including cone beam computed tomography, acquiring photograph(s) of theteeth, or the like. Optionally, calculating the oral surface map maycomprise identifying the location and geometry of oral and/or dentaldevices or implants (e.g., orthodontics). Generating an arrangement offluid openings may comprise identifying a size and shape of one or moreinterproximal regions that may be located between the teeth andpositioning a plurality of openings oriented parallel to correspondinginterproximal regions and located within a predetermined distance (e.g.,about 0 mm to about 10 mm) from the corresponding interproximal region.Alternatively or additionally, generating an arrangement of fluidopenings may comprise identifying occlusal, facial, lingual, mesial anddistal surfaces of the teeth and positioning a plurality of openingsoriented perpendicular to corresponding teeth surfaces and locatedwithin a predetermined distance (e.g., about 0 mm to about 10 mm) fromthe corresponding teeth surface. Alternatively or additionally,generating an arrangement of fluid openings may comprise identifying thesize and shape of teeth gingival margins and positioning a plurality ofopenings oriented at an angle from about 0° to about 90° relative to thetooth's surface at the gingival margin, for example, from about 45° toabout 135°, from about 0° to about 45°, from about 35° to about 55°,about 45°, etc. The fluid openings may be located a predetermineddistance (e.g., about 0 mm to about 10 mm) from the corresponding toothsurface or gingival margin.

One variation of a customized system for oral irrigation may comprise afluid reservoir and a customized oral insert in fluid communication withthe fluid reservoir, where the customized oral insert comprises anarrangement of fluid openings positioned to provide a customized fluidflow to one or more teeth of a user. The arrangement of fluid openingsis determined based on at least one characteristic of the one or moreteeth and/or gingiva. A fluid opening or nozzle may have a multi-lobeshape comprising a first lobe and a second lobe. The first lobe and thesecond lobe may define a lobe angle therebetween. The lobe angle maycorrespond with a curvature of a gingival margin of the one or moreteeth. In some variations, the first lobe has a first length and thesecond lobe has a second length, and the first and second lengths may bethe same or may be different. The first lobe may have a first width andthe second lobe may have a second width, and the first and second widthsmay be the same or different. Alternatively or additionally, at leastone of the first lobe and the second lobe may have a tapered portionsuch that a width of the lobe decreases along a length of the lobe.

In some variations, the multi-lobe shape may further comprise a thirdlobe. The first, second, and third lobes may be radially-arranged arounda center of the fluid opening. In some variations, the first, second,and third lobes may be radially-symmetric around a center of the fluidopening. The first lobe and the second lobe may define a lobe angletherebetween that corresponds with a curvature of a gingival margin ofthe one or more teeth, and the third lobe may be approximately alignedalong an interproximal space between the teeth.

Optionally, a customized system for oral irrigation may further comprisean oral alignment structure that comprises a plurality of contours thatcorrespond to the one or more teeth.

In some variations, the at least one characteristic may comprise thegeometry of each tooth and/or gingival margin. The at least onecharacteristic may comprises the size and shape of one or moreinterproximal regions between the teeth, and the arrangement of fluidopenings may comprise a plurality of openings oriented at an angle fromabout 0° to about 90° relative to a long axis of a tooth and may belocated within about 0 mm to about 10 mm from interproximal regions oneither side of the tooth. Alternatively or additionally, the at leastone characteristic may comprise the contours of the surfaces of theteeth, and the arrangement of fluid openings comprises a plurality ofopenings oriented at an angle from about 0° to about 90° relative to along axis of a tooth and located within about 0 mm to about 10 mm from asurface of the tooth. In some variations, the at least onecharacteristic may comprise the size and shape of gingival margins ofthe teeth, and the arrangement of fluid openings may comprise aplurality of openings oriented at an angle from about 0° to about 90°relative to a long axis of a tooth and may be located within about 0 mmto about 10 mm from a gingival margin of the tooth. Alternatively oradditionally, the at least one characteristic may comprise the geometryof oral and/or dental devices or implants. In some variations, thearrangement of fluid openings may comprise a first set of fluid openingson a first region of the oral insert and arranged to provide customizedfluid flow to a first set of teeth, and a second set of fluid openingson a second region of the insert opposite the first region of the oralinsert and arranged to provide customized fluid flow to a second set ofteeth of the user. The first region of the oral insert may be an upperregion of the oral insert and the first set of teeth comprises maxillaryteeth, and the second region of the oral insert may be a lower region ofthe oral insert, and the second set of teeth may comprise mandibularteeth.

A customized system for oral irrigation may also comprise a handle wherethe oral insert is coupled to the handle. The handle may comprise afluid flow management module that regulates fluid ingress to the oralinsert. The oral insert may further comprise one or more manifolds influid communication with the fluid flow management module. A number andgeometry of the one or more manifolds may be determined based on thearrangement of the fluid openings. The fluid flow management module maycomprise a pump in fluid communication with the fluid reservoir. Thefluid flow management module may comprise a manifold switcher configuredto vary fluid flow from the reservoir to the one or more manifolds ofthe oral insert. Optionally, the fluid flow management module maycomprise an additive-receiving port that is in fluid communication withat least one manifold of the oral insert, the additive-receiving porthaving an additive cartridge attachment mechanism. The fluid reservoirmay be a first fluid reservoir and the system may further comprise asecond fluid reservoir, and the fluid flow management module may beconfigured to vary fluid flow between the first and second fluidreservoirs and the one or more manifolds of the oral insert.

In some variations, the oral insert may be a first oral insert and thesystem may further comprise a second oral insert comprising a secondarrangement of fluid openings, where the first oral insert may beconfigured to provide customized fluid flow to one or more mandibularteeth of the user and the second oral insert may be configured toprovide customized fluid flow to one or more maxillary teeth of theuser. The system may further comprise a handle and the first oral insertand the second oral insert may be configured to be coupled to thehandle. For example, the first oral insert and the second oral insertmay be configured to be simultaneously coupled to the handle. In somevariations, the oral insert is a first oral insert and the systemfurther comprises a second oral insert comprising a second arrangementof fluid openings, where the first oral insert is configured to providecustomized fluid flow to one or more teeth on a left side of the userand the second oral insert is configured to provide customized fluidflow to one or more teeth on a right side of the user. The oral insertmay be a first oral insert and the arrangement of fluid openings is afirst arrangement of fluid openings, and the system may further comprisea second oral insert comprising an arrangement of fluid openings. Thefirst arrangement of fluid openings may be located along facial surfacesand/or lingual surfaces and/or occlusal surfaces of the user's teeth,and the second arrangement of fluid openings may be located atinterproximal spaces of between the user's teeth.

Also described herein are methods of generating an arrangement of fluidopenings in an oral insert. One variation of a method may compriseobtaining oral structure data comprising the size, shape, and locationof a user's teeth and gums, calculating an oral surface map thatidentifies locations of gingival margins, interproximal regions, andcontours of the incisal edges, occlusal, facial, lingual, mesial anddistal surfaces of the teeth, and generating an arrangement of fluidopenings in an oral insert, where the arrangement of fluid openings maycorrespond to the location of the gingival margins, interproximalregions, incisal edges, and contours of the occlusal, facial, lingual,mesial and distal surfaces of the teeth. Obtaining oral structure datamay comprise acquiring a 3-D dental scan, and/or acquiring X-ray dentalimages. Calculating the oral surface map may further compriseidentifying the location and geometry of oral and/or dental devices orimplants, for example, dental device comprises orthodontic appliances.Generating an arrangement of fluid openings may comprise identifying asize and shape of one or more interproximal regions are located betweenthe teeth, and positioning a plurality of openings oriented at an anglefrom about 0° to about 90° relative to a long axis of a tooth andlocated within about 0 mm to about 10 mm from interproximal regions oneither side of the tooth. Alternatively or additionally, generating anarrangement of fluid openings may comprise identifying incisal edges andocclusal, facial, lingual, mesial and distal surfaces of the teeth, andpositioning a plurality of openings oriented at an angle from about 0°to about 90° relative to a long axis of a tooth and located within about0 mm to about 10 mm from a surface of the tooth. In some variations,generating an arrangement of fluid openings may comprise identifying thesize and shape of gingival margins, and positioning a plurality ofopenings oriented at an angle from about 0° to about 90° relative to along axis of a tooth and located within about 0 mm to about 10 mm fromthe corresponding planar surface.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A depicts a top view of the oral anatomy of a user.

FIG. 1B depicts a partial cutaway side view of a tooth and surroundinggingiva.

FIG. 1C depicts a side view of teeth and surrounding gingiva.

FIG. 1D depicts one variation of a system for providing personalizedirrigation.

FIG. 1E depicts one variation of a customized mouthpiece or oral insert.

FIGS. 1F-1H depict one variation of a customized mouthpiece or oralinsert, where FIG. 1F is a bottom view of a mouthpiece, FIG. 1G is a topview of the mouthpiece of FIG. 1F, and FIG. 1H is a front view of themouthpiece of FIG. 1F.

FIG. 1I depicts a fluid flow pathway between a fluid reservoir, handle,and a customized mouthpiece or oral insert.

FIGS. 2A-2B are top views of teeth (above the occlusal surface of theteeth) and examples of fluid jets applied by different arrangements offluid nozzles or openings. FIG. 2C is a side perspective view of teethand their gingival margins, and examples of fluid jets applied bydifferent arrangements of fluid nozzles or openings.

FIG. 3A depicts variations of fluid nozzle or opening shapes.

FIG. 3B provides cross-sectional views of one variation of a fluidnozzle or opening.

FIGS. 3C-3E depict a cross-sectional view, a front view, and aperspective view, respectively, of one variation of a three-lobed fluidnozzle or fluid opening.

FIGS. 3F-3G depict a front view and a perspective view, respectively, ofone variation of a three-lobed fluid nozzle or fluid opening.

FIGS. 3H-3I depict a front view and a perspective view, respectively, ofone variation of a three-lobed fluid nozzle or fluid opening.

FIGS. 3J-3K depict a front view and a perspective view, respectively, ofone variation of a three-lobed fluid nozzle or fluid opening.

FIGS. 3L-3N depict a cross-sectional view, a front view, and aperspective view, respectively, of one variation of a two-lobed fluidnozzle or fluid opening.

FIGS. 30-3P depict a front view and a perspective view, respectively, ofone variation of a two-lobed fluid nozzle or fluid opening. FIG. 3Qdepicts a front view of another two-lobed fluid nozzle or opening.

FIGS. 3R-3S depict a front view and a perspective view, respectively, ofone variation of a two-lobed fluid nozzle or fluid opening.

FIGS. 3T-3U depict a front view and a perspective view, respectively, ofone variation of a two-lobed fluid nozzle or fluid opening.

FIGS. 3V-3AA depict front views of other variations of a three-lobedfluid nozzle or fluid opening.

FIGS. 4A-4C depict the experimental and simulated cleaning results of asample set of teeth using a circular or round-shaped fluid opening ornozzle. FIG. 4A is a front view of a sample set of teeth, FIG. 4Brepresents a simulated cleaning result of the teeth using acomputational fluid dynamics model, and FIG. 4C is a side view of thesample set of teeth along the interproximal space.

FIGS. 5A-5C depict the experimental and simulated cleaning results of asample set of teeth using a Y-shaped fluid opening or nozzle. FIG. 5A isa front view of a sample set of teeth, FIG. 5B represents a simulatedcleaning result of the teeth using a computational fluid dynamics model,and FIG. 5C is a side view of the sample set of teeth along theinterproximal space.

FIGS. 6A-6C depict the experimental and simulated cleaning results of asample set of teeth using a V-shaped fluid opening or nozzle. FIG. 6A isa front view of a sample set of teeth, FIG. 6B represents a simulatedcleaning result of the teeth using a computational fluid dynamics model,and FIG. 6C is a side view of the sample set of teeth along theinterproximal space.

FIGS. 7A-7B are schematic depictions of variations of manifoldconfigurations.

FIGS. 8A-8B are schematic depictions of variations of manifold and fluidreservoir configurations.

FIGS. 9A-9B are schematic depictions of manifold control methods.

FIG. 10 is a flow chart diagram with corresponding graphicalrepresentations of one variation of a method for generating a customizedoral insert or mouthpiece with a plurality of fluid openings positionedaccording to oral structure data.

DETAILED DESCRIPTION

Described herein are systems and methods for providing personalized oralirrigation. A system for personalized oral irrigation may comprise afluid reservoir and a customized oral insert in fluid communication withthe fluid reservoir. The oral insert may comprise an arrangement offluid openings positioned to provide a customized fluid flow over auser's teeth. In some variations, the oral insert may be customized toaccommodate a user's oral geometry. Fluid egress from the plurality offluid openings may clean multiple teeth simultaneously and the locationand geometry of the fluid openings with respect to specific and uniquestructures of the user's mouth may help facilitate expeditious and/oreffective cleaning of teeth surfaces. In some variations, the oralinsert may comprise a custom arrangement of a plurality of fluidopenings or nozzles where each of the nozzles is positioned to target aspecific dental feature or structure. Also described herein are methodsfor generating a pattern or arrangement of fluid openings on an oralinsert that are customized to a user's teeth and gums, as well as anyoral and/or dental devices or implants, for example, permanent andremovable dental restorations/prosthetics, orthodontic appliances, andetc. (e.g. crowns, bridges, implants, braces, retainers, dentures, andthe like). Methods may comprise obtaining oral structure data,identifying particular oral structures (e.g., gingival margins,interdental gingiva, interproximal regions, incisal edges, and contoursof the occlusal, facial, lingual, mesial and distal surfaces of theteeth), and generating a pattern or arrangement of fluid openings thatcorrespond to the specific oral structures.

The oral irrigation systems are described in the context of cleaning theteeth and/or disrupting biofilms that may form on or in between theteeth or restorations or around dental appliances, and within thegingival sulcus, but it should be understood that the systems describedherein may also be used for the application of medicaments orprophylactics to the oral cavity, teeth whitening, oral disinfection,antiseptic fluids, cleaning fluids, etc.

FIGS. 1A-1C are schematic depictions of oral anatomy and dentalstructures, illustrating the regions of the oral cavity describedherein. FIG. 1A depicts a top view of a set of teeth (140) of themandible or lower jaw (though similar terminology may be used to referto the teeth and structures of the maxilla or upper jaw). Each tooth(142) may have a facial surface (144) which is the region of the tooththat contacts the cheeks or lips and a lingual surface (146) which isthe region of the tooth that contacts (or is nearest to) the tongue.Facial surfaces may be, for example, the buccal surfaces of theposterior teeth and the labial surfaces of the anterior teeth. Lingualsurfaces may also be referred to as the palatal surfaces for maxillaryteeth. Posterior teeth may have an occlusal surface (148) and theanterior teeth may have an incisal edge or surface (150). The occlusal(or incisal) surface is the region of the tooth that aids in chewing,and/or faces across from the occlusal (or incisal) surface of theopposing tooth. The surface of a tooth facing away from the arch midlinemay be referred to as the distal surface (152) while the surface of atooth facing toward the arch midline (151) may be referred to as themesial surface (154). FIG. 1B depicts a side view of a single tooth(142), which may have a long axis (156) that extends along the longestdimension of the tooth (142) and/or is substantially perpendicular tothe occlusal surface (148) or incisal edge (150) of the tooth. The edgeor boundary of the gums (e.g., gingiva, gingival tissue) along thesurfaces of the teeth or closest to the occlusal surfaces or incisaledge of the teeth may be referred to as the gingival margin (158). Thegingival margin (158) may have one or more curves along the bottom ofeach tooth, and the radius of curvature and length of the gingivalmargin for each tooth may vary. A space or region (160) between thegingiva and the surfaces of the tooth may be referred to as a gingivalsulcus (160). Interdental gingiva (161) may be the gum tissue locatedbetween two adjacent teeth. FIG. 1C depicts a side view of a pluralityof teeth (142). The space or gap between each tooth (142) may bereferred to as the interproximal space or gap (162), and may be definedby the mesial surface of one tooth and the distal surface of theadjacent tooth, or the mesial surfaces of two teeth, in the case ofcentral incisor teeth. The left side of a user's oral cavity may be theregion of the oral cavity that is to the left of the interproximal spacebetween the two central incisors (e.g., to the left of the archmidline), and the right side of a user's oral cavity may be the regionof the oral cavity that is to the right of the interproximal spacebetween the two central incisors (e.g., to the right of the archmidline).

Systems

One variation of a system for personalized oral irrigation is depictedin FIG. 1D. The system (100) may comprise a base station (102) having afluid reservoir (103), a handle (104), and a customized oral insert ormouthpiece (106) coupled to the handle (104). One or more fluid conduitsor tubes (105) may connect the fluid reservoir (103) to the handle (104)and to the mouthpiece (106). The system (100) may optionally comprise acharging station (101) for the handle (104). The handle (104) maycomprise one or more control buttons (e.g., a start/stop button, a fluidflow adjustment dial), as may be desirable, which may be positionedvariously on the handle for ergonomic or efficient use. Alternatively oradditionally, one or more control buttons may be located on the basestation (102). For example, a system may comprise one or more controlbuttons on the base, and no control buttons on the handle. In othervariations, a personalized oral irrigation system may not have a handleat all, and may alternatively comprise one or more fluid conduits ortubes that directly connect the fluid from the base station reservoir tothe mouthpiece. The fluid retained in the fluid reservoir of acustomized oral irrigation system may be water, saline, a mouth wash orrinse, (e.g., containing fluoride and/or germicidal or other cleaningand/or teeth protective fluids), and/or any other desirable additive.The customized mouthpiece (106) may comprise a plurality of fluidopenings or nozzles that are arranged in accordance with the uniquegeometry of the user's oral cavity, gingival geometry, and dentalstructures (and any oral and/or dental devices or implants). Examples oforal and/or dental devices or implants may include, but are not limitedto, permanent and removable dental restorations/prosthetics, orthodonticappliances, and etc. (e.g., crowns, bridges, implants, braces,retainers, dentures, and the like). Each of the fluid openings ornozzles may be positioned to target a specific dental feature. Insidethe mouthpiece, the fluid openings or nozzles may be connected to one ormore internal manifolds. The inlets of these manifolds may extend fromthe back of the mouthpiece (or where desirable for ergonomic and/orefficient use) in the form of a standardized connector, to which ahandle and/or one or more tubes may be connected.

Customized Oral Insert or Mouthpiece

One variation of a customized oral insert or mouthpiece is depicted inFIG. 1E. Mouthpiece (120) may comprise a channel or trough or groove orslot that has one or more contours (122) that correspond with one ormore teeth of a user. The contours may be shaped based on optical and/ordigital impressions using intraoral scanners or photographs (e.g., 3-Dintraoral scans, 3-D scans of a dental impression), photographs, X-rays,physical impressions, intraoral and extraoral radiographs, computedtomography, including cone beam computed tomography, magnetic resonanceimaging, ultrasound, and the like. In some variations, a mouthpiece maynot have contours corresponding to one or more teeth, but may compriseone or more alignment features to help facilitate correct and consistentplacement and alignment of the mouthpiece within the mouth. For example,an oral insert or mouthpiece may comprise a channel or trough or grooveor slot defined by two side walls and a bottom wall that are sized tofit around the teeth (e.g., configured to contact facial surfaces,lingual surfaces, and occlusal surfaces of maxillary teeth and/ormandibular teeth). The side walls and bottom wall may have smoothedsurfaces and/or contours that may or may not correspond with theanatomical contours of the one or more teeth. In some variations, one ormore alignment features may be located within the trough to help seatthe teeth within the trough. For example, an alignment feature maycomprise protrusions, slots, or recesses that receive and/or articulatewith the user's teeth, gums, hard palate, soft palate, other oralstructures, and/or may have contours that correspond to one or moreteeth. These alignment features may help to ensure that the oral insertis seated in a desired position in the user's mouth. FIGS. 1F-1H depictone variation of an oral insert or mouthpiece (170) comprising a trough(172) that has a curve that corresponds with the curve of the maxillaryteeth or mandibular teeth (i.e., teeth along the curve of the maxilla ormandible). For example, the maxillary (or mandibular) teeth may belocated on the maxilla (or mandible) along a curve, and a curved troughof the oral insert may approximate that curve. While some variations ofthe oral insert may comprise a trough having contours that match theanatomical contours of a user's teeth, in this variation, the interiorwalls of the trough (172) may have smooth surfaces and/or contours orfeatures associated with the size, shape, placement and alignment of thefluid openings or nozzles with respect to a user's teeth. For example, aplurality of fluid openings or nozzles (174) may be located within thetrough, for example, along the two side walls of the trough forproviding fluid flow to the facial and/or lingual surfaces of the teeth.The fluid openings or nozzles (174) may include protrusions (as depictedin FIGS. 1F and 1G) that extend into the space of the trough, or may beflush along or recessed relative to the inner surface of side walls ofthe trough. As will be described further below, the fluid openings ornozzles (174) may be positioned at customized locations to direct fluidto specific regions of the teeth. For example, some fluid openings ornozzles may be located across from the interproximal spaces, and/oralong the gingival margins. In some variations, the spacing or distancebetween the fluid openings or nozzles may correspond with the distancebetween the interproximal spaces or the size and shape of the teeth.

While some oral inserts or mouthpieces may comprise a single trough tofit over either the maxillary teeth or the mandibular teeth, in othervariations, an oral insert or mouthpiece may comprise two opposingtroughs where one trough accommodates the maxillary teeth and the othertrough accommodates the mandibular teeth (i.e., so that both upper(maxillary) and lower (mandibular) teeth may be irrigated simultaneouslyor in series with a single mouthpiece). For example, as depicted in FIG.1H, the mouthpiece (170) comprises a first trough (172 a) that may beconfigured to fit over the mandibular teeth (e.g., a lower trough) and asecond trough (172 b) opposite the first trough that may be configuredto fit over the maxillary teeth (e.g., an upper trough). A first set offluid openings or nozzles may be located within the first trough (172 a)to provide customized fluid flow to the mandibular teeth and a secondset of fluid openings or nozzles may be located within the second trough(172 b) to provide customized fluid flow to the maxillary teeth. In somevariations, fluid openings or nozzles may be provided only in regions ofthe oral cavity for which fluid irrigation or infusion is desired. Forexample, some variations may comprise separate mouthpieces that eachprovide fluid flow to a select subset of teeth. This may be useful forapplications other than cleaning, for example, the targeted applicationof medicine, whitening solutions, etc. Any of the fluid openings ornozzles described herein may be used in either or both of the troughsfor providing customized fluid flow for each of the mandibular teeth andthe maxillary teeth.

Alternatively or additionally, some systems may comprise two or more ofany of the oral inserts or mouthpieces described herein. For example,some systems may comprise a first mouthpiece for providing fluid flowfor the maxillary teeth and a second mouthpiece for providing fluid flowfor the mandibular teeth. The system may comprise a single base station,and may have either one handle (where the first and second mouthpiecesmay be removably attached to the handle) or two handles (where the firstmouthpiece is attached to a first handle and the second mouthpiece isattached to a second handle). Alternatively or additionally, a systemmay have a first mouthpiece that has a first set of fluid openings ornozzles that are arranged to provide fluid flow to the interproximalspaces of the teeth (e.g., for a flossing function or effect) and asecond mouthpiece that has a second set of fluid openings or nozzlesthat are arranged to provide fluid flow across the facial and/or lingualand/or occlusal surfaces of the teeth (e.g., for a brushing or surfacecleaning function or effect). The first (e.g., flossing function)mouthpiece and the second (e.g., brushing function) mouthpiece may havetwo troughs for cleaning both the upper teeth and lower teethsimultaneously or in series, as described for the variation depicted inFIGS. 1F-1G. Alternatively, some systems may comprise a first mouthpiecethat has two troughs that accommodate the upper and lower teeth on aleft side of a user's oral cavity and a second mouthpiece that has twotroughs that accommodate the upper and lower teeth on a right side of anuser's oral cavity. Similarly, the system may comprise a single basestation and one or two handles, as described above.

The oral inserts or mouthpieces described herein may comprise aplurality of fluid openings or nozzles arranged based on the individualgeometry of a user's oral cavity and dental structures. Customizing theposition of the nozzles with respect to specific dental structures mayhelp facilitate cleaning efficacy. Cleaning efficacy may be achieved bygenerating a shear stress greater than the critical shear stress (i.e.,a shear stress threshold) at which biofilm or residue may be removedfrom the target surface or feature (e.g. tooth or gum structure). If anozzle is incorrectly aligned relative to the dental and/or gumstructures of a user, fluid jets may be improperly applied to the teethor gum structures, which may detract from cleaning efficacy and in somecases, may even push debris into a gum pocket (instead of flushingdebris out of a gum pocket). The positions of the nozzles in thearrangement of nozzles may be determined by locating the dental or gumfeature(s) targeted by the one or more nozzles, orienting the nozzlesuch that the applied fluid jet moves across or toward the feature suchthat biofilm or debris on the feature is disrupted or removed, andpositioning the nozzle at a location such that fluid from the nozzlestrikes the feature in a controlled fashion (e.g., with a consistentflow or pulsatile flow) to overcome the shear stress threshold at whichbiofilm or residue may be removed from the target surface or feature(e.g. tooth or gum structure). In some variations, customizedarrangement of nozzles may take into account any irregular tooth anatomyand/or orthodontic appliances, including supernumerary teeth, missing orunerupted teeth, fusion (when two developing teeth merge into onetooth—usually forming a groove that is prone to decay), gemination (whena developing tooth splits into two teeth—usually forming grooves thatare prone to decay), partially erupted teeth, and numerous otherformation or eruption issues that may cause irregular geometries. Thecustomized fluid opening or nozzle arrangements of the present inventionmay accommodate and clean the extra surfaces, interproximal regions,gingival margins, ridges, grooves, pits and fissures that mightotherwise be missed by non-customized mouthpieces or devices (i.e.,mouthpieces having fluid openings or nozzles that are not arranged basedon a user's oral and dental structures).

The oral inserts or mouthpieces described herein may also accommodatechanges in dental geometry. For example, a user may have a broken ormissing tooth, and/or may have new teeth or restorations. Somevariations of a mouthpiece may include one or more shields that may havecurves and/or contours that correspond to the surface contours of one ormore of the user's teeth. The shields may be mechanically attached orchemically bonded into the space or cavity of the mouthpiece thatcorresponds to the missing or broken tooth, and may extend from themouthpiece up to the gingival margin (e.g., a few millimeters over thegingival margin). The shields may help prevent fluid jets intended forthe missing or broken tooth from striking the recess where the tooth waspreviously located. The shields may also be used to shield especiallysensitive teeth or gums (e.g., due to tooth decay, retained roots,partially erupted teeth, and/or after a dental procedure) from fluidjets, as may be desirable for user comfort.

While the fluid openings or nozzles are described herein in the contextof fluid ingress (i.e., introducing fluid into the oral cavity), itshould be understood that one or more of the fluid openings or nozzlesmay be used for fluid egress (e.g., channeling fluid out of the oralcavity and/or coupled to a suction or vacuum chamber), as may bedesirable.

The oral insert or mouthpiece described herein may be manufacturedutilizing one or more 3-D Printing (also known as AdditiveManufacturing) processes which may include: Stereolithography Apparatus(SLA), Polymer Jetting, Powder Deposition, Binder Jetting, SelectiveLaser Sintering (SLS), Fused Deposition Modeling (FDM), Fused FilamentFabrication (FFF), Directed Energy Deposition (DED), Direct Metal LaserSintering (DMLS), Selective Laser Melting (SLM), Electron Beam Melting(EBM), Laminated Object Manufacturing (LOM), Rapid Liquid Printing(RLP), BioPrinting, Self Assembly Printing (Also known as 4D printing)or a hybrid system that utilizes a variety of 3D printing process.Manufacturing may also include a hybrid process that utilizes 3DPrinting and robotics, 3D printing and conventional manual milling orComputer Numerically Controlled (CNC) machining, or 3D printing andinjection molding or over-molding. Manufacturing may also include asystem for varying hardness, flexibility, color, or texture dependingupon process and materials used. Materials may include, UV-curablephotopolymers such as 3D Systems™ VisiJet SL Clear™, 3DSystems™ AccuraClearVue™ NextDent™ Model Clear™ or Stratasys™ Med620™, UV curableceramics, powder polymers, powder metals, powder alloys, powder ceramic,powered organic material, filament-based plastics, filament-basedmetals, filament based ceramics, filament-based organic materials, ormay be comprised of a variety of plastic, metal, ceramic, organicmaterials or biological materials that may be grown in a laboratoryenvironment which may be end user specific or manufactured from aspecific user's genetic data or cells as a base material. A template fora customized mouthpiece may specify the curves and contours of themouthpiece to accommodate a user's teeth and oral cavity, as well as thelocation, number, shape and size of the arrangement of fluid openings ornozzles.

Mouthpieces (120, 170) may comprise one or more internal fluid cavitiesor manifolds connected to the fluid openings or nozzles, and the fluidinlets (124) to the manifolds may extend from the mouthpieces (120, 170)to engage with fluid ports of a handle and/or fluid conduits or tubes.One variation of a handle is depicted in FIG. 1I. Handle (130) maycomprise a pump (132) and a switching manifold (134), both of which arein fluid connection with the base station reservoir and enclosed withina handle housing. In variations where the oral insert comprises aplurality of manifolds, the switching manifold (134) of the handle maymultiplex and/or regulate fluid flow in each of the plurality ofmanifolds. Handle (130) may also comprise an electronics control boardand one or more user inputs or control buttons, which may be incommunication with the electronics control board. The electronicscontrol board may receive and/or relay commands to regulate the fluidflow into the handle and to the mouthpiece. Optionally, some variationsof a handle or reservoir may comprise one or more heating elements. Theheat element may be adjusted by a user (in a pre-programmed or real-timefashion) to set the temperature of the fluid at a comfortable level. Insome variations, the temperature of the fluid may be set at levels toimprove cleaning efficacy (e.g., higher temperatures may help facilitateremoval of hydrophobic food or biofilm residues, such as residues withfatty acids and/or oils, and/or dissolve and/or soften hardened foodresidues), and/or increase chemical activity of entrained, therapeuticadditives. A system may comprise one or more thermal control units (e.g.a heater or chiller) at various locations within the system, forexample, in the base of the reservoir (location 131) and/or in the pump(132) and/or switching manifold (134). For example, a heating elementmay comprise an electrical-resistance type heating element, and/or acooling element may be a thermoelectric cooler (e.g. a solid-statedevice such as a Peltier device). The heating and/or cooling element(133) may be located within the handle (130) and may be thermallyconnected to one or more of the pump and/or switching manifold and/orreservoir. Alternatively or additionally, the fluid may also be heatedby thermal energy generated by a pump motor (e.g., pump (132)). The heatbyproduct generated by the electric motor (e.g., generated within thecopper electrical motor windings) may be used to heat the fluid to adesired and/or beneficial temperature. As the fluid moving through themotor may carry the heat energy away from the motor, this may have theadditional benefit of simultaneously cooling the motor itself. In somevariations, the fluid may be routed directly through the copper motorwindings (i.e. the fluid is in direct contact with the surface of theelectrical conductors), or it could be routed through aspecifically-engineered “water jacket” (e.g. fluid channels) around,inside, or otherwise in thermal communication with the heat-generatingcopper motor windings. Alternatively or additionally, heat generated bythe electronics (e.g. motor drive semiconductors, computer processor ofthe base station) may also be used to heat the fluid as it passesthrough the system.

Described below are examples of fluid opening or nozzle arrangementsthat are customized to particular dental structures or features. Whilethe position of the fluid openings or nozzles may be tailored to targetone dental structure or feature, it should be understood that theposition of fluid openings or nozzles may be determined based onoptimizing fluid flow and/or biofilm or debris removal from more thanone dental structure or feature.

Fluid Opening or Nozzle Placement Customized for Teeth Surfaces

An oral insert and/or mouthpiece may comprise one or more sets of fluidopenings or nozzles for removing biofilm or debris from the surface of atooth (e.g., the contours of the occlusal, facial, lingual, mesial anddistal surfaces of the teeth). In one variation, the fluid openings ornozzles for removing biofilms and/or debris from a tooth's surface maybe oriented approximately perpendicular to the surface and placed withina predetermined distance (e.g., from about 0 mm to about 10 mm) of thetooth (to overcome a shear stress threshold of greater thanapproximately 0.014 psi across the target region). Alternatively oradditionally, the fluid openings or nozzles may be oriented at any anglebetween 0° to about 90° relative to the long axis of a tooth, e.g., fromabout 0° to about 30° (for example, for back molars), from about 35° toabout 55°, from about 45° to about 90°, about 45°, etc. FIG. 2A is adiagrammatic representation of fluid openings or nozzles in positionsthat may provide adequate or consistent fluid flow for removing biofilmor debris (e.g., food residue) from a facial surface or lingual surfaceof a tooth. As depicted there, fluid openings or nozzles (204) and (206)of an oral insert may each be positioned about 1 mm away (to overcome ashear stress threshold of greater than approximately 0.014 psi acrossthe target region) from the tooth surface (208), for example, thelingual and/or facial surfaces, and oriented such that the fluid jet(201) is approximately perpendicular to the tooth surfaces (208).Alternatively or additionally, the fluid openings or nozzles may beoriented at any angle between 0° to about 90° relative to the long axisof a tooth, e.g., from about 0° to about 30°, from about 35° to about55°, from about 45° to about 90°, about 45°, etc. In some variations, atleast some of the fluid openings or nozzles (204, 206) may be alignedrelative to the lingual and/or facial surfaces of the teeth, and/orlocated between the interproximal spaces of the teeth (i.e., not alignedrelative to the interproximal spaces of the teeth). For some variationsof an oral insert and/or mouthpiece that is intended to simulate theeffect of brushing or cleaning the lingual and/or facial and/or occlusaltooth surfaces, some or all the of the fluid openings and/or nozzles maybe aligned relative to the lingual and/or facial surfaces and few (ifany) fluid openings or nozzles are aligned relative to the interproximalspaces. Nozzles may be located along the mesial or distal sides of teethif no adjacent tooth is present. In some variations, fluid openings ornozzles may be located at an angle from about 0° to about 90° relativeto a long axis of a tooth, e.g., from about 0° to about 30°, from about20° to about 35°, from about 35° to about 55°, from about 45° to about90°, about 45°, etc. The shape of the fluid opening may be any shapedescribed herein (e.g., as described further below and depicted in FIGS.3A-3AA).

Fluid Opening or Nozzle Placement Customized for Interproximal Surfaces

An oral insert and/or mouthpiece may comprise one or more sets of fluidopenings or nozzles for removing biofilm or debris from interproximalsurfaces. In one variation, the fluid openings or nozzles for removingbiofilm and/or debris from a tooth's surface, including supragingivaland subgingival regions, may be oriented parallel to the tangents of theinterproximal region and positioned within a predetermined distance(e.g., from about 0 mm to about 10 mm) from the interproximal region (toovercome a shear stress threshold of greater than approximately 0.014psi across the target region). The shape of the opening or nozzle mayalso be selected such that the resultant fluid jet has a width andheight that corresponds with a width and height of the interproximalregion, including the shape of the interdental gingiva, allowing foradequate shear stress distribution on the targeted region. FIG. 2B is adiagrammatic representation of fluid openings or nozzles in positionsthat may provide adequate or consistent fluid flow for removing biofilmand/or debris from interproximal surfaces (213). As depicted there,nozzles (218) and (220) may each be oriented along and/or parallel to atangent (221) and (223) respectively of the interproximal surfaces (213)of two teeth, such that the fluid jet (219) may be approximatelyperpendicular to the interproximal tooth surfaces. Alternatively oradditionally, the fluid openings or nozzles may be oriented such thatthe fluid jet may have any angle between 0° to about 90° relative to thelong axis of a tooth, e.g., from about 0° to about 30° (for example, forback molars), from about 35° to about 55°, from about 45° to about 90°,about 45°, etc. In some variations, at least some of the fluid openingsor nozzles (218, 220) may be aligned relative to the interproximalspaces between the teeth (i.e., not aligned relative to the lingualand/or facial surfaces of the teeth). For some variations of an oralinsert and/or mouthpiece that is intended to simulate the effect offlossing and/or removing residue from the interproximal spaces, some orall the of the fluid openings and/or nozzles may be aligned relative tothe interproximal spaces and few (if any) fluid openings or nozzles arealigned relative to the lingual and/or facial surfaces. In somevariations, fluid openings or nozzles may be located at an angle fromabout 0° to about 90° relative to the long axes of the teeth adjacent tothe interproximal space, e.g., from about 0° to about 30, from about 35°to about 55°, from about 45° to about 90°, about 45°, etc. The shape ofthe fluid opening may be any shape described herein (e.g., as describedfurther below and depicted in FIGS. 3A-3AA).

Fluid Opening or Nozzle Placement Customized for Gingival Margins

An oral insert and/or mouthpiece may comprise one or more sets of fluidopenings or nozzles for removing biofilm or debris from gingival margins(including supragingival, and/or subgingival regions, and/or gingivalsulci). In one variation, the fluid openings or nozzles for removingbiofilms from a tooth's surface may be oriented upwards at any anglefrom about 0° to about 90°, e.g., about 70° to about 110°, about 90°,relative to the tooth's surface at the gingival margin (or the long axisof the tooth) and placed within about 0 mm to about 10 mm of the gumline (to overcome a shear stress threshold of greater than approximately0.014 psi across the target region). FIG. 2C is a diagrammaticrepresentation of fluid openings or nozzles in positions that mayprovide adequate or consistent fluid flow for removing biofilm from agingival margin. As depicted there, nozzle (234) may be oriented suchthat the resultant fluid flow (235) is any angle from about 0° to about90°, e.g., about 70° to about 110°, about 90°, to the surface(represented by the dotted line 232) of the tooth at the gingival marginor long axis of the tooth (e.g., parallel to 232), which may helpprevent damage to gingival attachment to the tooth. In some variations,fluid openings or nozzles may be located at an angle from about 0° toabout 90° relative to a long axis of a tooth. The shape of the fluidopening may be any shape described herein (e.g., as described furtherbelow and depicted in FIGS. 3A-3AA).

Nozzle Design for Customized Fluid Profiles and Coverage

The shape of the fluid openings or nozzles may be selected to expand thearea that is covered by a fluid jet, and/or adjust the fluid pressure orshear stress distribution at a local tooth surface. Examples of fluidopening or nozzle shapes (as viewed along the fluid path, face-on, alongthe central axis of the opening) are depicted in FIG. 3A. A fluidopening may be shaped as a circle (where the diameter may be adjustedper a user's oral geometry), a line (which may be located in alignmentwith an interproximal space and may have a length that corresponds witha dimension, e.g., length, of an interproximal space), a curve or arc(where the length and radius of curvature may be adjusted per the lengthand curvature of the user's gingival margins, which may vary on atooth-by-tooth basis). A fluid opening may also have a multi-linearand/or multi-lobular radial shape and/or an irregular shape that may betailored according to the geometry of the user's dental geometry. Insome variations, identified dental or oral structures may be mapped tospecific opening or nozzle shapes. Optionally, the lengths and contoursof each nozzle could be adjusted to match individual oral features ofthe user and/or to tune the fluid coverage area to accommodateindividual oral features. Alternatively or additionally, the shape of afluid opening or nozzle may be selected from a library of tunabledesigns and/or tuned to match individual oral features. For example, asdepicted in FIG. 3B, tunable parameters of a circular or spot shapednozzle (300) may include, but are not limited to, orifice diameter (D),length (L), and fillet radii (R). For example, the diameter (D) may befrom about 0.2 mm to about 1.5 mm. Alternatively or additionally, thesize and shape of a fluid opening or nozzle may be determined bydefining the desired fluid jet coverage area, the resultant shearstress, fluid jet velocity, pressure or flowrate, and iterating throughvariations of tunable parameters to arrive at a completely custom nozzlegeometry. For example, fluid jets from the nozzles may generate shearstresses of greater than approximately 0.014 psi on the targeted region,pressures from about 10 psi to about 150 psi, and flowrates from about0.3 l/min to about 20 l/min.

FIGS. 3C-3AA depict various fluid opening or nozzle shapes andgeometries that may be used in an oral insert or mouthpiece, alone or incombination with fluid openings of different shapes and sizes, as may bedesirable. A fluid opening or nozzle may be connected to an internalmanifold within the oral insert or mouthpiece via a channel or lumen.The channel or lumen may be shaped as a cylinder and may have a length(L_(in)) and a diameter (d). The length (L_(in)) may be from about 20 mmto about 20 mm, and the diameter (d) may be from about 2 mm to about 5mm. A first end of the channel may connect to an internal manifold whilethe second end of the channel may terminate in an opening (i.e., fluidopening) having a size and shape that may be customized to the user'steeth. In some variations, there may be a curved surface (S) disposedover at least a portion of the fluid opening. For example, the curvedsurface (S) may be defined as a hemisphere with a diameter d, or as anellipsoid where one of its semi-axes is of a length d/2. In somevariations, the fluid opening may have a multi-lobular shape having Nlobes and where the lobes have an angular distribution (Φ₁ . . .Φ_(N-1)). In some variations, there may be N number V-grooves with aspecified groove angle (θ_(groove)) and an offset (a) of the V-grooves.The number and orientation of the lobes may be customized based on oralanatomy and desired fluid flow profile over that oral anatomy. Forexample, the diameter (d), groove angle (θ_(groove)) and groove offset(a) may be adjusted to attain a fan jet that increases in width as ittravels outward from the fluid opening with a desired fluid sheetthickness (e.g., dimension or extent of the fan jet that isperpendicular to its travel direction) and spray angle (e.g., angularspan of the fan jet). For example, diameter (d) may be from about 2 mmto about 5 mm as described above, groove angle (θ_(groove)) may be fromabout 10° to about 170°, and groove offset (a) may be from about 0 mm toabout 3 mm. The customization of these parameters may facilitate thecustomization of a fluid flow profile according to the geometry of theoral features (e.g., facial, lingual, and/or occlusal surfaces, and/orinterproximal spaces and/or gingival margins) of any individual tooth orgroup of teeth that are desired to be irrigated or cleaned. For example,when the fluid openings and/or nozzles are targeting interproximalregions and gingival margins of the tooth, the angular distribution ofthe lobes (Φ₁ . . . Φ_(N-1)) may be determined by the angle of theinterdental gingiva. The dimensions of the nozzle or fluid openingsdescribed above may be adjusted based on the geometry of the gingivalmargins adjacent to the targeted interproximal space and/or the desireddepth of penetration into the gingival sulcus to attain a spray angleand sheet thickness that removes biofilm and debris from theinterproximal space.

Fluid openings with a three lobe multi-lobe shape may be suitable fordirecting fluid through interproximal spaces to facilitate a flossingeffect and/or to remove debris or residue from between teeth. The lobesmay be arranged to correspond with the vertical and/or horizontal extentor dimension of an interproximal space and interdental gingiva. Forexample, to the extent that the shape of the interproximal space betweenmost teeth can be approximated by a triangle, one or more lobes mayapproximate the vertical dimension or height of the triangle (i.e., thevertical dimension of the interproximal space that is parallel to thelong axis of the tooth), and one or more lobes may approximate thehorizontal dimension of the triangle (i.e., the horizontal dimension ofthe interproximal space that is perpendicular to the long axis of thetooth). In some variations, the fluid opening may have a multi-lobeshape where the lobes are radially arranged around a center of the fluidopening. Angular separation between lobes may be uniform (e.g., threelobes with angular separation of 120° between each, four lobes withangular separation of 90° each, etc.) or may vary (e.g., three lobeswhere two lobes have an angular separation of 180° and the third lobehas an angular separation of 90° from the other two, i.e., T-shaped). Insome variations, the lobes may not be radially symmetric (e.g., twolobes having a 120° angle between them). Widths of each of the lobes maybe the same or different from each other, depending on the geometry ofthe interproximal space between the individual teeth. Each lobe may havea width (i.e., the dimension that is perpendicular to the radial axis)and the width may be uniform across the length of the lobe or may varyacross the length of the lobe. For example, some multi-lobe fluidopenings may lobes that taper outward (e.g., width decreases away fromthe center of the opening) or inward (e.g., width decreases toward fromthe center of the opening).

FIGS. 3C-3K depict variations of fluid openings with a three-lobed ortri-lobal shape. FIGS. 3C-3E depict one variation of a nozzle or fluidopening (310) having first, second, and third lobes (312 a, 312 b, 312c) that are arranged in a radially symmetric fashion (i.e., angulardistribution is such that Φ₁=120°, Φ₂=120°. The fluid opening (310) maybe at one end of a channel or lumen (314), which may have a lengthL_(in) and diameter d as described above. The three-lobed or tri-lobalshape may be referred to as a Y-shaped nozzle. In the variation of FIGS.3C-3E, the Y-shaped nozzle may comprise three V-grooves (311) thatcreates the three-lobed shape of the fluid opening and may also create acurved surface (S) disposed over at least a portion of the fluid opening(310). The Y-shaped nozzle may generate a tri-lobal, fan-like, sheetspray. Optionally, fluid may also flow along the channels or groovescreated by the V-grooves. This may help the oral insert or mouthpiece todirect flow into the interproximal space and/or along the gingivalmargins, including subgingival regions, and more evenly distribute flowand shear stress coverage.

FIGS. 3F-3K depict other variations of a three-lobed or Y-shaped fluidopening or nozzle. FIGS. 3F-3G depict one variation of a fluid opening(316) that has three lobes similar to the opening (310), but withV-grooves (317) that are shorter than the V-grooves (311). The lobes ofthe fluid openings (310) and (316) may be wider than they are long.FIGS. 3H-3I depict one variation of a fluid opening (318) that has threelobes where the lobes (319) are longer than they are wide (e.g., lengthsof the lobes may be from about 2 to about 6 times greater than thewidth). The fluid opening (318) may also be spaced apart from the innerchannel (320) by a distance (a), where the distance (a) may be fromabout 0.25 mm to about 10 mm. The inner channel diameter may taperoutward from the diameter (d) of the cylindrical portion (i.e., thediameter of the circumscribing circle containing the cross-section ofthe fluid path increasing along the distance (a)) such that the interiorwalls of the inner channel meets the tips of the lobes (319), forexample, such that the channel leading up to the fluid opening isdefined by a loft between the multi-lobed fluid opening and a circularcross section upstream of the fluid opening. In variations where thelength between the tips of the fluid opening lobes is less than thediameter (d) of the inner channel (e.g., the largest dimension of thefluid opening is less than the diameter of the inner channel), thediameter of the inner channel may taper inward from the diameter (d) ofthe cylindrical portion (i.e., the diameter of the circumscribing circlecontaining the cross-section of the fluid path decreasing along thedistance (a)) such that the interior walls of the inner channel meetsthe tips of the lobes. FIGS. 3J-3K depict one variation of a fluidopening (322) that has three lobes where the lobes (323) are also longerthan they are wide. The fluid opening (322) may also be spaced apartfrom the inner channel (324) by a distance (a), where the distance (a)may be from about 0.25 mm to about 10 mm. However in contrast to thefluid opening (318), the end of the inner channel diameter (324)terminates with a shape that matches the shape of the fluid opening(322). The distance (a) between the Y-shaped cylindrical end portion(325) and the fluid opening (322) may be from about 0.25 mm to about 10mm. In some variations, the fluid opening or nozzle (322) may bedesigned without any V-grooves, but instead may be designed bytranslating the fluid opening by a fixed distance up to the innerchannel, which may be manufactured by extrusion methods. While certaindesign or manufacturing methods are described herein as examples ofgenerating fluid openings with particular shapes, it should beunderstood that any design or manufacturing methods may be used asdesired, e.g., extrusion techniques, any 3-D printing techniques, and/orlaser cutting techniques.

FIGS. 3L-3U depict variations of fluid openings with a two-lobed orbi-lobal shape. FIGS. 3L-3N depict one variation of a nozzle or fluidopening (330) having first and second lobes (332 a, 332 b) that arearranged in a bilaterally symmetric fashion (i.e., angular distributionis such that) Φ₁=120°. The fluid opening (330) may be at one end of achannel or lumen (334), which may have a length L_(in) and diameter d asdescribed above. The two-lobed or bi-lobal shape may be referred to as aV-shaped nozzle. In the variation of FIGS. 3L-3N, the V-shaped nozzlemay comprise two V-grooves (331) that creates the two-lobed shape of thefluid opening and may also create a curved surface (S) disposed over atleast a portion of the fluid opening (330). The V-flat nozzle containstwo V-grooves, generating a bi-lobal fan sheet spray. This may help todirect fluid flow along the gingival margin and may help to increaseshear stress coverage in the supragingival and subgingival regions,while still maintaining adequate or substantial coverage of theinterproximal space. Optionally, fluid may also flow along the channelsor grooves created by the V-grooves.

FIGS. 30-3U depict other variations of a two-lobed or V-shaped fluidopening or nozzle. FIGS. 30-3Q depict one variation of a fluid opening(336) that has two lobes similar to the opening (330), but withV-grooves (337) that are shorter than the V-grooves (331). The lobes ofthe fluid openings (330) and (336) may have widths that are similar to(or greater than) their lengths. FIGS. 3R-3S depict one variation of afluid opening (338) that has two lobes where the lobes (339) are longerthan they are wide (e.g., lengths of the lobes may be from about 2 toabout 6 times greater than the width). The fluid opening (338) may alsobe spaced apart from the inner channel (340) by a distance (a), wherethe distance (a) may be from about 0.25 mm to about 10 mm. The innerchannel diameter may taper outward from the diameter (d) of thecylindrical portion (i.e., the diameter of the circumscribing circlecontaining the cross-section of the fluid path increasing along thedistance (a)) such that the interior walls of the inner channel meetsthe tips of the lobes (339), for example, such that the channel leadingup to the fluid opening is defined by a loft between the multi-lobedfluid opening and a circular cross section upstream of the fluidopening. In variations where the length between the tips of the fluidopening lobes is less than the diameter (d) of the inner channel (e.g.,the largest dimension of the fluid opening is less than the diameter ofthe inner channel), the diameter of the inner channel may taper inwardfrom the diameter (d) of the cylindrical portion (i.e., the diameter ofthe circumscribing circle containing the cross-section of the fluid pathdecreasing along the distance (a)) such that the interior walls of theinner channel meets the tips of the lobes. FIGS. 3T-3U depict onevariation of a fluid opening (342) that has two lobes where the lobes(343) are also longer than they are wide. The fluid opening (342) mayalso be spaced apart from the inner channel (344) by a distance (a),where the distance (a) may be from about 0.25 mm to about 10 mm.However, in contrast to the variation depicted in FIGS. 3R-3S, the endof the inner channel diameter (344) terminates with a shape that matchesthe shape of the fluid opening (342). The distance (a) between theV-shaped cylindrical end portion (345) and the fluid opening (342) maybe from about 0.25 mm to about 10 mm. In some variations, the fluidopening or nozzle (342) may be designed without any V-grooves, butinstead may be designed by translating the fluid opening by a fixeddistance up to the inner channel, which may be manufactured by extrusionmethods. While certain design or manufacturing methods are describedherein as examples of generating fluid openings with particular shaped,it should be understood that any design or manufacturing methods may beused as desired, e.g., extrusion techniques, any 3-D printingtechniques, and/or laser cutting techniques.

FIGS. 3V-3AA depict additional variations of fluid openings or nozzleshaving a three-lobe or tri-lobal shape, but with varying values for theangles Φ_(lobe), θ_(groove), and diameter (d). These variants may beselected from a design library and tuned to match an individual user'soral features, and/or may help to increase shear stress coverage acrosstarget regions or surfaces of the teeth. FIG. 3V depicts one variationof a fluid opening with three lobes that are radially symmetric and thewidths of the lobes may be substantially constant as the lobes extendoutward, and may have a curved lobe ending. FIG. 3W depicts onevariation of a fluid opening with three lobes that are radiallysymmetric and the widths of the lobes may taper or narrow as the lobesextend outward, and may have a pointed lobe ending. The lengths of thelobes may be about 1.5 to about 2.5 times the widths of the lobes. FIG.3X depicts one variation of a fluid opening with three lobes that areradially symmetric and the widths of the lobes may taper or narrow asthe lobes extend outward, and may have a pointed lobe ending. Thelengths of the lobes may be about 3 to about 5 times the widths of thelobes. FIG. 3Y depicts one variation of a fluid opening with three lobesthat where two of the lobes are about 180° from each other and the thirdlobe is about 90° from the other two lobes (e.g., forming a T-shape).The third lobe may have a length that is greater than or equal to thelengths of the first and second lobes. FIG. 3Z depicts one variation ofa fluid opening with three lobes that are arranged similarly to thefluid opening in FIG. 3Y (i.e., T-shaped), however, the widths of thelobes may taper or narrow as the lobes extend outward, and may have apointed lobe ending. The lengths of the lobes may be about 1.5 to about2.5 times the widths of the lobes. FIG. 3AA depicts one variation of afluid opening with three lobes that are arranged similarly to the fluidopening in FIG. 3Y (i.e., T-shaped), and the widths of the lobes maytaper or narrow as the lobes extend outward, and may have a pointed lobeending. The lengths of the lobes may be about 3 to about 5 times thewidths of the lobes. While the fluid openings or nozzles of FIGS. 3V-3AAare depicted as having V-grooves, it should be understood that in othervariations, there may not be V-grooves. While certain design ormanufacturing methods are described herein as examples of generatingfluid openings with particular shapes, it should be understood that anydesign or manufacturing methods may be used as desired, e.g., extrusiontechniques, any 3-D printing techniques, and/or laser cuttingtechniques.

Experimental Results

Experimental results have demonstrated that the fluid opening or nozzleshape affects and/or impacts the area that is cleaned. FIGS. 4A-4Cdepict the experimental and simulated cleaning results of a sample setof teeth using a circular or round-shaped fluid opening or nozzle, FIGS.5A-5C depict the experimental and simulated cleaning results of a sampleset of teeth using a Y-shaped fluid opening or nozzle (e.g., the fluidopening of FIGS. 3C-3E), and FIGS. 6A-6C depict the experimental andsimulated cleaning results of a sample set of teeth using a V-shapedfluid opening or nozzle (e.g., the fluid opening of FIGS. 3L-3N). Foreach of the experiments for FIGS. 4A, 5A, 6A (front view) and 4C, 5C, 6C(side view, depicting the surface of the teeth along the interproximalspace), a biofilm mimicking surrogate was applied over a set of fourteeth models arranged in a row and fluid introduced to the teeth througha fluid opening or nozzle having a round shape, Y-shape, and V-shape. Inall test cases, nozzles were positioned perpendicular to the long axisof the teeth. The average flow rate and time evaluated across nozzledesigns was consistent for all experiments. FIGS. 4B, 5B, 6B arecomputational fluid dynamics (CFD) models of the fluid flow fromopenings or nozzles having a round shape, Y-shape, and V-shape,respectively, depicting the shear stress profiles or patterns from eachof these nozzle shapes. The simulation employed the same nozzle geometryas the experiments. In the simulation, the nozzles were aligned (e.g.,aimed) at the interproximal spaces of the four teeth to match theexperiments. Simulation results were calculated using a finite volumemethod based steady-state incompressible flow solver. Momentum,pressure, and mass continuity solution residuals were reduced to below anormalized value of 1e-5 to ensure adequate numerical convergence.Material properties of pure water at 20° C. (room temperature) wasassumed. Simulation nozzle inlet mass flow rates were set to themeasured mass flow rates from the corresponding experiments above.Teeth, gum, and experimental apparatus surfaces were treated as no-slip,no-penetration walls with outlet surfaces surrounding the lower portionof the gum surfaces to allow for drainage of injected fluid. Forturbulence modeling, the k-epsilon two equation model was used.

As may be seen in FIGS. 4A and 4C, a stationary, round nozzle may removeor clean the surrogate along the interproximal spaces, however, a roundnozzle does not appear to clean the surrogate from the gingival margin,and also appears to clean little, if any, surrogate from the facial andlingual surfaces of the teeth. These experimental results are consistentwith the simulation results depicted in FIG. 4B. In a customized oralinsert or mouthpiece, round nozzles or fluid openings may be placed atlocations that align with the interproximal spaces of a user's teeth.For example, an oral insert may comprise round nozzles or fluid openingsthat are aligned relative to the interproximal spaces of the teeth andlocated toward the top or occlusal surfaces of the teeth (as opposed tobeing located toward the bottom along the gingival margins).

As may be seen in FIGS. 5A and 5C, a stationary Y-shaped nozzle mayremove or clean the surrogate along both the interproximal spaces andlarge portions of the facial and lingual surfaces, as well as regionsalong the gingival margin, however, a Y-shaped nozzles does not appearto clear the surrogate along the entire length of the gingival margin.These experimental results are consistent with the simulation resultsdepicted in FIG. 5B. In a customized oral insert or mouthpiece, Y-shapednozzles or fluid openings may be placed at locations that align with theinterproximal spaces of a user's teeth. For example, an oral insert maycomprise Y-shaped nozzles or fluid openings that are aligned relative tothe interproximal spaces of the teeth and located toward the bottomalong the gingival margins of the teeth (as opposed to being locatedtoward the top toward the occlusal surfaces). The length of the lobes ofa particular Y-shaped fluid opening for a particular tooth may beselected to approximate the height of the interproximal region and thelength of gingival margins of that tooth and/or adjacent teeth. In somevariations, the Y-shaped lobe may be oriented such that a first lobe maybe oriented vertically along the vertical extent of an interproximalspace between a first and second tooth, and the second lobe may beoriented along the gingival margin of the first tooth and the third lobemay be oriented along the gingival margin of the second tooth. Thelength of the second lobe may be about half the length of the gingivalmargin of the first tooth (and/or may approximate the entire length ofthe gingival margin of the first tooth) and the length of the third lobemay be about half the length of the gingival margin of the second tooth(and/or may approximate the entire length of the gingival margin of thesecond tooth). The length of the first lobe that may be aligned along avertical extent (e.g., dimension parallel to the long axis of the tooth,or height) of an interproximal space may approximate the height of theinterproximal space.

As may be seen in FIGS. 6A and 6C, a stationary V-shaped nozzle mayremove or clean the surrogate along both the interproximal regions andthe gingival margins. The V-shaped nozzle appears to clear moresurrogate from the interproximal space than the Y-shaped nozzle, therebyeffecting a “flossing” effect (i.e., cleaning the interproximal spacesand along the gingival margins). These experimental results areconsistent with the simulation results depicted in FIG. 6B. In acustomized oral insert or mouthpiece, V-shaped nozzles or fluid openingsmay be placed at locations that align with the interproximal spaces of auser's teeth. For example, an oral insert may comprise V-shaped nozzlesor fluid openings that are aligned relative to the interproximal spacesof the teeth and the interdental gingiva and located toward the bottomalong the gingival margins of the teeth (as opposed to being locatedtoward the top toward the occlusal surfaces). The length of the lobes ofa particular V-shaped fluid opening for a particular tooth may beselected to approximate the length of gingival margins of that toothand/or adjacent teeth, and may approximate the geometry of theinterdental gingiva. In some variations, the V-shaped lobe may beoriented such that a first lobe may be oriented along the gingivalmargin of a first tooth and the second lobe may be oriented along thegingival margin of a second tooth adjacent to the first tooth. Thelength of jet generated by the second lobe may be about half the lengthof the gingival margin of the first tooth (and/or may approximate theentire length of the gingival margin of the first tooth) and the lengthof the jet generated by the third lobe may be about half the length ofthe gingival margin of the second tooth (and/or may approximate theentire length of the gingival margin of the second tooth).

An oral insert or mouthpiece may comprise one or more fluid openings ornozzles with a variety of shapes to address and clean different areas ofthe teeth. That is, different nozzle shapes may be combined on an oralinsert to achieve both “flossing” effects and “brushing” effects (i.e.,to floss, brush, or otherwise clean the facial, lingual, mesial, distal,and occlusal surfaces and the incisal edges). For example, an oralinsert may comprise a plurality of V-shaped nozzles or Y-shaped nozzlesaligned relative to the interproximal spaces and/or along the gingivalmargins/interdental gingiva to facilitate a flossing effect, and aplurality of round nozzles aligned relative to the facial and/or lingualsurfaces of teeth to facilitate a brushing effect. Y-shaped and/orV-shaped nozzles may also be aligned relative to the facial and/orlingual surfaces of teeth. Alternatively, a plurality of round nozzlesmay be aligned relative to an interproximal space but located toward thetop or occlusal surfaces of the teeth, while a plurality of V-shapedand/or Y-shaped nozzles may be aligned relative to the interproximalspace but located toward bottom or gingival margins of the teeth. Insome variations, all (or nearly all) of the fluid openings or nozzles ofa mouthpiece may be the same one type to facilitate a single function(e.g., a mouthpiece with all V-shaped nozzles or Y-shaped nozzles may bea flossing mouthpiece, a mouthpiece with all rounded nozzles may be abrushing mouthpiece). A system may comprise a first “flossing”mouthpiece (e.g., with nearly V-shaped and/or Y-shaped nozzles) and asecond “brushing” mouthpiece (e.g., with nearly all round nozzles). Anycombination of any of the nozzles or fluid openings described herein maybe combined with any number of oral inserts or mouthpieces (e.g., in thesame or different troughs of a mouthpiece, etc.), as may be desirable.

Manifold Customization

As described above, an oral insert or mouthpiece may comprise one ormore manifolds in fluid connection with the plurality of fluid openingsor nozzles. FIGS. 7A-7B are schematic depictions of one variation of amanifold arrangement that may be used with any of the oral irrigationsystems described herein. An individual manifold may regulate fluid flowto a set of nozzles, and may adjust the fluid flow to those nozzlesseparately from the fluid flow to a different set of nozzles (which maybe connected to a different manifold). In some variations, the one ormore manifolds of a mouthpiece may be connected to a single fluid inlet(e.g., via a conduit from the handle or base station reservoir).Manifolds may facilitate fluid ingress or egress, as may be desirable. Amanifold may have several parameters that can be tuned to control thefluid velocity at each nozzle, including, but not limited to a volume ofmain manifold (700) (V_(M)) and/or a volume of each sub-manifold (702)(V_(SM)) that feeds a nozzle (704). One or more nozzles may beconfigured to release fluid into the oral cavity should the pressure inthe manifold exceed a threshold fluid pressure. These release nozzlesmay have larger apertures than the non-release nozzles and may be placedsuch that they simply irrigate the oral cavity while relieving excessmanifold pressure. The parameters of the main manifold (700) and/or thesub-manifolds (702) may be selected by iterating through differentvalues and simulating the fluid flow through the manifolds and thenozzles until a desired flow rate, flow profile, or shear stressdistribution is attained. In some variations, evolutionary algorithmsmay be used to permute and simulate the manifold and nozzle geometry toarrive at a set of manifold and nozzle parameters and geometries thatmeet the desired fluid flow characteristics.

Manifold Count Customization

In some variations, fluid openings or nozzles may be distributed acrossa customizable number of manifolds within an oral insert or mouthpiecein order to accommodate differently-sized mouths and to manage theamount of fluid flowing into the mouth simultaneously. In somevariations, a base station (710) may direct fluid into each manifold(712) and (714) in phases during the cleaning cycle. A customizedmouthpiece may comprise, for example, an embedded RFID chip (716), orany similar identification technology, that communicates, to the basestation, the number of manifolds present in the mouthpiece. This mayallow the base station (710) to only direct fluid to existing manifolds.The base station may direct a constant or pulsing (e.g., from about 1 Hzto about 25 Hz), but user-adjustable, flow into each manifold of themouthpiece. For example, control buttons on the handle and/or basestation may allow a user to adjust the fluid pressure to a comfortablelevel. Fluid pressure may also be reduced for pediatric mouthpieces, orfor those with orthodontic appliances. The RFID chip in the mouthpiecemay store patient-specific data that may be transmitted to a RFID readerin the base station, and optionally, the base station may recommend afluid flow mode based on patient-specific data (e.g., age, size,preferred fluid flow parameters, compliance metrics, etc.). In somevariations, the base station may automatically adjust fluid pressuredepending on the size of the person's mouth, the number of manifolds intheir unique mouthpiece, size and shapes of the manifolds, and the like.

Multi-Reservoir and/or Multi-Manifold Variations

Some oral irrigation systems may comprise multiple fluid reservoirs anda multi-piston pump to independently control the flow of fluid from eachof the fluid reservoirs through their respective manifolds. In thisvariation, additives may be included in some reservoirs for infusion tocertain regions of the oral cavity while limiting exposure of thoseadditives to other regions of the oral cavity. FIG. 8A depicts onevariation of a system (800) comprising a plurality of separate fluidreservoirs (802), a multi-piston pump (804) that has separate fluidconduits (806) that are each in communication with a separate fluidreservoir, and a plurality of manifolds (808) in the mouthpiece (810)that are each in communication with a corresponding fluid conduit (806).Each manifold (808) may provide fluid to a plurality of fluid openingsor nozzles (812) The use of multiple reservoirs with a multi-piston pumpmay facilitate the delivery of customized additives to each independentmouthpiece manifold. For example, additives (803) introduced into asubset of reservoirs (802) may be introduced only in the correspondingsubset of manifolds (808) and fluid openings (812).

Alternatively or additionally, some systems may comprise a single fluidreservoir and a single-piston pump. In-line injections of additives tocertain fluid conduits in the pump may with a manifold-switch design mayfacilitate delivery of additives to one manifold and not another. Forexample, as depicted in FIG. 8B, a system (820) may comprise a singlefluid reservoir (822) a pump (824) that has a switching manifold (825)that alternates connectivity between the fluid reservoir and theseparate fluid conduits (826) that are in communication with separatemanifolds (828) of a mouthpiece (830). An additive may be introduced toan individual manifold (828) via a cartridge (823) inserted into thedesired manifold in the mouthpiece or handle. This cartridge may lastmultiple uses (e.g., the entire lifetime of the mouthpiece, one or moremonths, three months, etc.), and may facilitate a slow, controlleddelivery of the additive. This may be achieved using the Venturi effect,in conjunction with a check valve, and/or via diffusion through apermeable membrane, and/or erosion of a solid additive.

The ability to direct therapeutic flow to specific areas of the mouthmay provide an additional opportunity for user-specific customization.These customization settings may be provided to the device via softwareupdates provided wirelessly, via a wired connection, or could beprovided in non-volatile electronic memory (e.g. ROM, EEPROM, OTPROM, orsimilar) located within the periodically-replaceable mouthpiece. Iflocated in a memory device in the mouthpiece, the information may betransmitted to the device via electrical contacts, RF or optical signal,or similar method. This user-specific information may also be providedto the device via the reading of non-electronic storage means, forexample, a QR code, bar code, or other similar means.

Manifold Operation

FIG. 9A is a schematic representation of one example of a method forcontrolling a manifold to provide oral irrigation with any of thesystems described herein. As an example, an 8-piston pump may deliverfluid flow to 8 independent manifolds (which may in turn connect to oneor more associated nozzles) could be controlled in such a way as todeliver additional flow to a specific tooth, or group of teeth. Onepiston may be fired repeatedly several times in a row to deliveradditional flow to a manifold before continuing to fire the rest of thepistons. Some variations may comprise multiple, separate, single-pistonpumps, each connected to a different manifold, and increased flow to oneportion of the oral cavity (e.g., the portion of the oral cavitycorresponding to the fluid openings or nozzles associated with manifold3) may be attained by driving one piston pump faster than the rest.Alternatively or additionally, a single-piston pump (or any type ofpump) may be used in conjunction with a multi-channel manifold switcher(e.g., as described above in FIG. 8B), where the switcher may beprogrammed to “dwell” longer on a particular fluid conduit or manifold.This may direct additional flow to a specific manifold, to thecorresponding set of nozzles to provide irrigation to a specific toothor set of teeth (e.g., to deliver enhanced therapy to that tooth orteeth). For example, the manifold switcher in its baseline state may beprogrammed to direct one cycle of the piston pump to each manifold. Toprovide enhanced therapy to a particular region of the oral cavity, themanifold switcher may be programmed to pause on one manifold (i.e.,provide fluid communication from the reservoir to a particular conduitor manifold) for more than one cycle of the piston pump beforecontinuing to cycle through the remainder of the manifolds.

Methods

FIG. 10 depicts one variation of a method for creating a custom oralinsert or mouthpiece comprising an arrangement or pattern of fluidopenings that are tuned to the unique geometry of a user's mouth. Method(500) may comprise obtaining (502) oral structure data comprising thesize, shape, and location of a user's teeth and gums. Obtaining oralstructure data may comprise acquiring optical and/or digital impressionsusing intraoral scanners or photographs (e.g., 3-D intraoral scans, 3-Dscans of a dental impression), photographs, X-rays, physicalimpressions, intraoral and extraoral radiographs, computed tomography,including cone beam computed tomography, magnetic resonance imaging,ultrasound, and the like. These measurements may be taken across thesurface(s) of each tooth (e.g., lingual, facial, occlusal surfaces), inthe interproximal regions, and spanning the gingival margin, includingabout 10 mm of the gingiva. The measurements may be accurate to within0.25 mm.

Method (500) may then comprise identifying teeth surfaces (e.g.,lingual, facial, occlusal surfaces), gingival margins, and/orinterproximal features. For example, method (500) may comprisecalculating (504) an oral surface map that identifies locations ofgingival margins (510), interproximal spaces (512), incisal edges (513),and contours of the occlusal, facial, lingual, mesial and distal of theteeth (for example, in FIG. 10, facial surfaces are indicated with acircular dot (514)).

Method (500) may then comprise generating (506) an arrangement of fluidopenings in the trough(s) of the oral insert. The location of fluidopenings in the trough(s) (i.e., top and bottom troughs, right and lefttroughs, etc.) may correspond to the location of the gingival margins,interdental gingiva, interproximal regions, incisal edges, and contoursof the occlusal, facial, lingual, mesial and distal surfaces of theteeth. The openings or nozzles may be located and/or oriented asdescribed above. For example, each surface, gingival margin, andinterproximal feature may be identified in the model (in step (504)) andone or more nozzles may be placed in a trough of the mouthpiece with anyorientation, distance and nozzle shape, as described above, to provideadequate shear stress distribution across of the feature. Fluid openingsor nozzles may be located along the side walls and/or bottom wall of themouthpiece trough. In some variations, fluid openings or nozzlesdisposed along the side walls may be positioned to apply fluid flow tofacial and/or lingual surfaces and/or interproximal spaces and/orgingiva, while the fluid openings or nozzles located along the bottomwall may be positioned to apply fluid flow to the occlusal surfacesand/or incisal edges of the teeth. Fluid openings or nozzles on thebottom wall of the trough may face the occlusal surface and/or incisaledge of a tooth, and may be angled with respect to the long axis of thetooth, e.g., from about 0° to about 30, from about 35° to about 55°,from about 45° to about 90°, about 45°, etc. Nozzles may have a maximumcoverage area and if a dental feature is determined to be too large forthe maximum fluid coverage area attainable by a single nozzle, multiplenozzles can be placed for that dental feature to provide complete fluidcoverage. In some variations, V-shaped and/or Y-shaped fluid openings ornozzles may be located on the mouthpiece such that they align with theidentified interproximal spaces (512), and/or interdental gingiva (515),and may be located toward the bottom of the teeth, along the gingivalmargins (510). The diameter of the inner fluid channel, groove angle,the dimensions and shape of the fluid openings or nozzles may beadjusted to correspond with the geometry and positioning ofinterproximal spaces, teeth surfaces, and/or gingiva. For example,multiple V-shaped and/or Y-shaped nozzles may be disposed along thelength of a gingival margin if the spread or width of fluids from asingle nozzle is insufficient to cover the entire length of the gingivalmargin. For taller crowns, round nozzles may be aligned relative to theidentified interproximal spaces (512), but toward the top surfaces(e.g., occlusal surfaces and/or incisal edges) of the teeth in order toextend the coverage achieved by the V-shaped and/or Y-shaped nozzles.The diameter of the round nozzle and/or the lengths, widths, angulardistribution, and/or rotational orientation of a multi-lobe shapednozzle may be selected based on the dimensions of the lengths, heights,widths, and curvature of the gingival margins, interproximal spaces,facial and/or lingual surfaces, and/or occlusal and/or incisal surfaces.In some variations, the largest dimension of a fluid opening (e.g.,diameter for a round opening, distance between opposing lobe tips for amulti-lobular opening, etc.) may be selected to approximate orcorrespond to the width of the interproximal space along the gingivalmargin and/or interdental gingiva. A dimension of the fluid opening ornozzle (e.g., width, length, diameter) may be selected to approximate orcorrespond with the length and/or curvature of the gingival margin of atooth. For example, in some variations, the method (500) may comprisecalculating an average length and/or radius of curvature (ROC) of all ofthe gingival margins of a user's teeth, and this average length or ROCmay be used to size the Y-shaped or V-shaped lobes such that theresulting jets span approximately half the average length of thegingival margins. For example, individual teeth having gingival marginsthat have lengths that are greater than one standard deviation from theaverage gingival margin length could have their corresponding nozzledimensions or shapes adjusted to accommodate the unique or individuallength of their gingival margin. Alternatively or additionally, acustomized oral insert or mouthpiece may comprise fluid openings ornozzles that have a multi-lobe structure, where the arrangement of thelobes is selected to align with the grooves on the occlusal surfaces ofteeth. In some variations, the position and/or orientation of fluidopenings or nozzles may be determined by the volume of the oral cavityin the proximity of the target tooth or teeth. That is, for regions ofthe oral cavity where the user's cheeks, tongue, and/or other oralanatomical structures constrain the space around the tooth or teeth,fluid openings or nozzles have a limited range of angular orientations.For example, for regions of the oral cavity where the distance betweenthe surface of a teeth and the cheek, tongue, or other oral structure isless than or equal to about 7 mm, the nozzles may be positioned at anangle from about 0 degrees to 35 degrees from the long axis of a tooth.For regions of the oral cavity where the distance between the surface ofa tooth and the cheek is more than about 7 mm, the nozzles may bepositioned at an angle from about 0 degrees to about 90 degrees, e.g.,from about 40 degrees to about 80 degrees, about 45 degrees, about 60degrees, etc.

In addition to anatomical data of the oral cavity, user input may alsobe used in the customization of the oral insert. For example, the usermay indicate areas of tooth or gum sensitivity, and the oral insert maycomprise fluid openings or nozzles in the corresponding area thatprovide indirect fluid flow, and/or less shear stress to those teeth. Afluid opening shape that provides more diffuse fluid irrigation may bepositioned in the oral insert at regions that overlay the sensitiveteeth or gums. For example, the oral insert may have fluid openings withlarger diameters or dimensions to reduce the fluid pressure to thoseareas, and/or may have fewer fluid openings in those areas. Optionally,the user may also indicate areas where food debris tends to accumulate(e.g., perhaps due to user preferred chewing motions or patterns), andan oral insert may comprise fluid openings or nozzles that particularlytarget and direct fluid of higher pressure to increase the shear stressapplied to those areas. For example, multiple fluid openings may beoriented and angled at one area (e.g., an interproximal space that isparticularly large or prone to accumulate debris) to flush that areafrom multiple angles with a greater cumulative pressure or shear stresscoverage than may be applied by a single fluid opening.

Optionally, a customized mouthpiece design may be evaluated to identifyany design errors. In some variations, a verification check may comprisea manual or automated Design Rules Check (DRC) to ensure that allmouthpiece features meet a predetermined set of rules or criteria. Oneexample of rule check may comprise ensuring that no walls are too thinfor the mouthpiece material. A more advanced check may include a manualor automated Finite Element Analysis (FEA) of the mouthpiece design. Thecustomized mouthpiece design may also be verified to evaluate efficacyof biofilm and/or debris removal. A manual or automated ComputationalFluid Dynamics (CFD) simulation can be run to ensure that each fluidnozzle produces the desired fluid velocity and coverage. If thissimulation shows areas where the desired fluid velocity and coveragehave not been achieved, the corresponding nozzles can be adjusted andthe simulation re-run. This iterative cycle could be manual or automatedwith software.

The invention claimed is:
 1. A customized system for oral irrigationcomprising: a fluid reservoir; and a customized oral insert in fluidcommunication with the fluid reservoir, wherein the customized oralinsert comprises a plurality of manifolds in fluid communication withthe fluid reservoir and an arrangement of fluid openings positioned toprovide a fluid flow customized to one or more teeth of a specific user,wherein a shape and size of the arrangement of fluid openings and theplurality of manifolds are customized to at least one characteristic ofthe one or more teeth and/or gingiva of the specific user; and a fluidswitcher in fluid communication with the fluid reservoir and theplurality of manifolds, wherein the fluid switcher is configured tocycle fluid flow individually into each manifold of the plurality ofmanifolds, wherein a first manifold is configured to direct fluid flowto a first set of teeth and a second manifold is configure to directfluid flow to a second set of teeth that are mesial relative to thefirst set of teeth, wherein the first and second set of teeth aremandibular teeth, or the first and second set of teeth are maxillaryteeth.
 2. The system of claim 1, wherein at least one fluid opening ofthe arrangement of fluid openings has a multi-lobe shape comprising afirst lobe and a second lobe.
 3. The system of claim 2, wherein themulti-lobe shape further comprises a third lobe.
 4. The system of claim2, wherein the first lobe and the second lobe define a lobe angletherebetween.
 5. The system of claim 4, wherein the lobe angle isconfigured to correspond with a curvature of a gingival margin of theone or more teeth.
 6. The system of claim 3, wherein the first lobe andthe second lobe define a lobe angle therebetween that corresponds with acurvature of a gingival margin of the one or more teeth, and the thirdlobe is approximately aligned along an interproximal space between theteeth.
 7. The system of claim 2, wherein the first lobe has a firstlength and the second lobe has a second length, and the first and secondlengths are the same.
 8. The system of claim 2, wherein the first lobehas a first length and the second lobe has a second length, and thefirst and second lengths are different.
 9. The system of claim 2,wherein the first lobe has a first width and the second lobe has asecond width, and the first and second widths are different.
 10. Thesystem of claim 2, wherein the first lobe has a first width and thesecond lobe has a second width, and the first and second widths are thesame.
 11. The system of claim 2, wherein at least one of the first lobeand the second lobe have a tapered portion such that a width of the lobedecreases along a length of the lobe.
 12. The system of claim 1, furthercomprising an oral alignment structure that comprises a plurality ofcontours that correspond to the one or more teeth.
 13. The system ofclaim 1, wherein the at least one characteristic comprises the geometryof each tooth and/or gingival margin.
 14. The system of claim 1, furthercomprising a handle and wherein the oral insert is coupled to thehandle, and wherein the handle comprises a fluid flow management modulethat regulates fluid ingress to the oral insert.
 15. The system of claim14, wherein the plurality of manifolds are in fluid communication withthe fluid flow management module, wherein a number and geometry of theplurality of manifolds are determined based on the arrangement of thefluid openings.
 16. The system of claim 15, wherein the fluid flowmanagement module comprises a pump in fluid communication with the fluidreservoir.
 17. The system of claim 14, wherein the fluid reservoir is afirst fluid reservoir and the system further comprises a second fluidreservoir, and the fluid flow management module is configured to varyfluid flow between the first and second fluid reservoirs and theplurality of manifolds of the oral insert.
 18. The system of claim 1,wherein the arrangement of fluid openings comprises a first set of fluidopenings on a first region of the oral insert and arranged to providecustomized fluid flow to a first set of teeth, and a second set of fluidopenings on a second region of the insert opposite the first region ofthe oral insert and arranged to provide customized fluid flow to asecond set of teeth of the user.
 19. The system of claim 1, wherein theoral insert is a first oral insert and the system further comprises asecond oral insert comprising a second arrangement of fluid openings,wherein the first oral insert is configured to provide customized fluidflow to one or more mandibular teeth of the user and the second oralinsert is configured to provide customized fluid flow to one or moremaxillary teeth of the user.
 20. The system of claim 1, wherein the oralinsert is a first oral insert and the system further comprises a secondoral insert comprising a second arrangement of fluid openings, whereinthe first oral insert is configured to provide customized fluid flow toone or more teeth on a left side of the user and the second oral insertis configured to provide customized fluid flow to one or more teeth on aright side of the user.
 21. The system of claim 1, wherein the oralinsert is a first oral insert and the arrangement of fluid openings is afirst arrangement of fluid openings, and the system further comprises asecond oral insert comprising a second arrangement of fluid openings,wherein the first arrangement of fluid openings are located along facialsurfaces and/or lingual surfaces and/or occlusal surfaces of the user'steeth, and the second arrangement of fluid openings are located atinterproximal spaces of between the user's teeth.